Surgical Intervention for Morbidly Obese Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00289705|
Recruitment Status : Active, not recruiting
First Posted : February 10, 2006
Last Update Posted : February 2, 2017
The purpose is to study whether the positive effects from obesity surgery in adults also can be achieved when adolescent subjects are operated.
Our hypothesis is that the effects concerning weight loss, health improvement and improved quality of life will be as good in adolescents as in adults.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Diabetes Hypertension||Procedure: Surgery||Phase 3|
Severe obesity in the adolescence is a major concern since there is a constant rise in prevalence worldwide. There is a need of effective tools to treat those patients since the natural course with conservative treatment is very pessimistic. I. e. most of the subjects having a BMI >40kg/m2 in the adolescence will remain morbidly obese also in their adult life.
The three largest centres in Sweden treating obese children (Stockholm, Gothenburg and Malmö) will offer patients fulfilling the inclusion criteria to be operated with laparoscopic gastric bypass. If not willing to be operated they could join the study as a control case.
Subjects will be investigated at the baseline concerning physical health status and existence of medical risk factors but also regarding their quality of life, eating habits and physical activity. They will subsequently be follow over a ten year period regarding these variables.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgical Intervention With Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity in Adolescence - a Matched Control Study|
|Study Start Date :||February 2006|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||February 2018|
Laparoscopic gastric bypass
Laparoscopic Roux-en-Y gastric bypass
No Intervention: 2
Traditional treatment for obesity
- BMI development [ Time Frame: 10 years ]
- Medical risk factors, incidence of diseases (such as diabetes, hypertension etc), quality of life, socioeconomic development, eating pattern. [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289705
|Queen Silvias Children Hospital|
|Gothenburg, Göteborg, Sweden|
|Sahlgrenska University Hospital, Dept of Surgery|
|Gothenburg, Sweden, 41345|
|Dept of Pediatrics, MAS|
|National center for child obesity, Karolinska Huddinge|
|Stockholm, Sweden, 14186|
|Principal Investigator:||Torsten Olbers, MD, PhD||Sahlgrenska University Hospital, Sweden|
|Study Chair:||Clude Marcus, Prof, MD||Dept of Pediatrics, Karolinska University Hospital, Huddinge|
|Study Chair:||Staffan Mårild, MD, PhD||Queen Silvias Childs Hospital, Gothenburg|
|Study Chair:||Carl-Erik Flodmark, MD, PhD||Dept of Pediatrics, MAS, Malmö|